Bibloc

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language!
Bibloc (BisoHEXAL 5 mg)
5 mg, film-coated tablets
Bisoprolol fumarate
Bibloc and BisoHEXAL 5 mg are different trade names for the same medicinal product.
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Bibloc is and what it is used for
2. What you need to know before taking Bibloc
3. How to take Bibloc
4. Possible side effects
5. How to store Bibloc
6. Contents of the pack and other information

1. What Bibloc is and what it is used for

Bibloc belongs to a group of medicines called beta-blockers. These protect the heart from overactivity.
Bibloc is used to treat:

• high blood pressure
• angina pectoris (chest pain)
• heart failure characterized by breathlessness during exertion or fluid retention in the body. In such cases, Bibloc may be used as additional treatment for heart failure already being treated with other medicines.

2. Important information before using Bibloc

When not to use Bibloc

• If the patient is allergic to bisoprolol fumarate or to any of the other ingredients of this medicine (listed in section 6).
• If the patient has cardiogenic shock – a severe heart condition characterized by rapid, weak pulse, low blood pressure, cold and clammy skin, weakness, and fainting.
• If the patient has ever experienced wheezing or severe bronchial asthma, as breathing problems may occur.
• If the patient has a slow heart rate (less than 60 beats per minute). In case of doubt, consult a doctor.
• If the patient has very low blood pressure.
• If the patient has severe circulatory disorders (which may cause tingling, paleness, or blueness of fingers and toes).
• If the patient has severe heart rhythm disorders.
• If the patient has sudden heart failure or existing heart failure that is decompensated and requires hospital treatment.
• If the patient has an accumulation of acids in the body, diagnosed as metabolic acidosis. The doctor will provide information on this.
• If the patient has a tumour of the adrenal medulla (so-called chromaffin tumour) that is untreated.

If in any doubt, consult a doctor.

Warnings and precautions

Before starting treatment with Bibloc, consult a doctor:

• if the patient has wheezing or breathing difficulties (bronchial asthma), they should be using bronchodilator medications simultaneously. A higher dose of beta-2 mimetics may be required.
• if the patient has diabetes. Bibloc tablets may mask symptoms of low blood sugar (such as rapid heartbeat, palpitations, or excessive sweating).
• if the patient does not consume food of consistent consistency.
• if the patient is undergoing anti-allergy treatment. Bibloc may increase sensitivity to allergens and intensify the severity of hypersensitivity reactions. Adrenaline treatment may then be ineffective and a higher dose may be required.
• if the patient has first-degree atrioventricular block (a heart conduction disorder).
• if the patient has Prinzmetal's angina (chest pain caused by spasm of the coronary arteries supplying blood to the heart muscle).
• if the patient has impaired blood flow in the hands and feet.
• if the patient is undergoing a procedure under anaesthesia, inform the doctor, hospital staff, or dentist about all medications being taken.
• if the patient is taking calcium channel blockers such as verapamil and diltiazem. Concomitant use is not recommended (see also "Other medicines and Bibloc").
• if the patient has psoriasis (a recurring skin condition characterized by skin peeling and dry skin rash), currently or in the past.
• if the patient has a chromaffin tumour (adrenal medulla tumour). Before prescribing Bibloc, the doctor must initiate appropriate treatment.
• if the patient has thyroid dysfunction. Bisoprolol tablets may mask symptoms of hyperthyroidism.

There is currently no therapeutic experience with the use of Bibloc in heart failure in the following patients:

• with type I diabetes treated with insulin
• with severe kidney disease
• with severe liver disease
• with certain heart diseases
• who have had a myocardial infarction within the last 3 months.

Treatment of heart failure with Bibloc requires regular medical monitoring. This is absolutely essential, especially at the beginning and after discontinuation of treatment.

Bibloc must not be stopped suddenly unless absolutely necessary. In patients with hypertension and angina pectoris accompanied by heart failure, treatment should not be discontinued abruptly. The dose should be gradually reduced by half every week.

Consult a doctor if any of the warnings described apply to the patient or applied in the past.

Bibloc and other medicines

Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription. Some medicines must not be taken at the same time as Bibloc, while others require specific adjustments, e.g. dose changes.

In every case, inform the doctor about taking or receiving, in addition to Bibloc, the following medicines:

• medicines used to control blood pressure or heart rhythm disorders (e.g. amiodarone, amlodipine, clonidine, cardiac glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, phenytoin, propafenone, quinidine, rilmenidine, verapamil);
• sedatives and medicines used in the treatment of psychosis (mental illness), e.g. barbiturates (also used in epilepsy treatment), phenothiazines (also used to treat nausea and vomiting);
• medicines used to treat depression, e.g. tricyclic antidepressants, MAO-A inhibitors;
• medicines used for anaesthesia during surgery (see also "Warnings and precautions");
• certain painkillers (e.g. acetylsalicylic acid, diclofenac, indomethacin, ibuprofen, naproxen);
• medicines used to treat bronchial asthma, nasal congestion, or certain eye conditions such as glaucoma (increased intraocular pressure) or pupil dilation;
• certain medicines used in shock treatment (e.g. adrenaline, dobutamine, noradrenaline);
• mefloquine (a medicine used to treat malaria);
• rifampicin (an antibiotic);
• ergotamine derivatives (used to treat migraine). All these medicines and Bibloc may affect blood pressure and/or heart function.
• insulin or other antidiabetic medicines. There is a possibility of enhanced glucose-lowering effect and masking of symptoms of low blood sugar.

Bibloc and alcohol

Alcohol may intensify dizziness and drowsiness caused by Bibloc. In such cases, alcohol consumption should be avoided.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine. Bibloc may have harmful effects on pregnancy and/or the fetus. The risk of premature delivery, miscarriage, low blood sugar in the newborn, and slowed fetal heart rate increases. For this reason, Bibloc should not be used during pregnancy.

It is not known whether bisoprolol passes into breast milk; therefore, the use of Bibloc during breastfeeding is not recommended.

Driving and operating machinery

This medicine may cause fatigue, drowsiness, or dizziness. If these symptoms occur, the patient should not drive or operate machinery. Be aware that such symptoms may occur especially at the beginning of treatment, when switching from another medicine, and when alcohol is consumed simultaneously.

Bibloc contains lactose and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Bibloc

This medicine should always be taken as directed by your doctor or pharmacist. If you have any
doubts, you should contact your doctor or pharmacist.
Your doctor will inform you how many tablets to take. The medicine should be taken in the morning, before, during or after
breakfast. The tablet(s) should be swallowed with a small amount of water. Tablets must not be
chewed or crushed.

High blood pressure/angina pectoris
Adults
Your doctor will determine the dose individually.
The recommended starting dose is 5 mg once daily.
The usual dose for adults is 10 mg once daily. Your doctor may decide to increase or decrease this dose. The maximum dose is 20 mg once daily.

Severe renal or hepatic impairment
In patients with severe renal impairment: the maximum dose is 10 mg per day.

Elderly
Dose adjustment is usually not necessary. Your doctor will start treatment with the lowest possible dose.

Heart failure (reduced cardiac contractility)
Before starting treatment with Bibloc, patients usually already receive an angiotensin-converting enzyme (ACE) inhibitor, a diuretic, or a cardiac glycoside (a heart and antihypertensive medicine).
The dose will be gradually increased until the appropriate dose for the patient is reached:
1.25 mg once daily for 1 week. If this dose is well tolerated, it may be increased to:
2.5 mg once daily for the next week. If this dose is well tolerated, it may be increased to:
3.75 mg once daily for the next week. If this dose is well tolerated, it may be increased to:
5 mg once daily for the next 4 weeks. If this dose is well tolerated, it may be increased to:
7.5 mg once daily for the next 4 weeks. If this dose is well tolerated, it may be increased to:
10 mg once daily (maintenance dose).
The maximum dose is 10 mg once daily.
Your doctor will determine the optimal dose for the patient, taking into account, among other factors, any adverse effects.
After the first dose of 1.25 mg, your doctor will monitor the patient's blood pressure, pulse rate, and heart function.

Hepatic or renal impairment
Your doctor will increase the dose particularly cautiously.

Elderly
Dose adjustment is usually not necessary.
If you feel that the effect of Bibloc is too strong or too weak, inform your doctor or pharmacist.

The tablet should be placed on a hard, flat surface with the score side facing upwards. Press with the thumb in the center of the tablet. The tablet will split into two halves. Pressing the center of each half will yield 4 parts.

Duration of treatment
Bibloc is generally used long-term.

Use in children and adolescents
Due to lack of data on the use of Bibloc in children and adolescents, its use is not recommended in this age group.

Taking more Bibloc than recommended
If you accidentally take more Bibloc than recommended, you must contact your doctor or pharmacist immediately. You should bring any remaining tablets or this leaflet with you so that medical personnel know which medicine has been taken. Symptoms of overdose may include dizziness, feeling faint, tiredness, shortness of breath and/or wheezing. There may also be a slow heart rate, low blood pressure, inadequate cardiac contractility, and low blood glucose levels (which may cause feelings of hunger, excessive sweating, and palpitations).

Missing a dose of Bibloc
Do not take a double dose to make up for a missed dose. Take the usual dose as soon as you remember, and then return to your normal dosing schedule the next day.

Stopping treatment with Bibloc
Treatment with Bibloc must not be stopped suddenly. If treatment is abruptly discontinued, the condition may worsen. The dose should be gradually reduced over several weeks, as directed by your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If an adverse effect is serious, occurs suddenly, or worsens rapidly, contact your doctor immediately to prevent severe reactions.
The most serious adverse effects are related to heart function:

• Slowing of the heartbeat (may occur in more than 1 in 10 people)
• Worsening of existing heart failure (may occur in fewer than 1 in 10 people)
• Slow or irregular heartbeat (may occur in fewer than 1 in 100 people)

If the patient experiences dizziness, weakness, or difficulty breathing, contact a doctor as quickly as possible.
If the patient experiences more severe allergic reactions, which may include swelling of the face, neck, tongue, lips or throat, or difficulty breathing, seek immediate medical attention.

The following adverse effects are listed below according to their frequency of occurrence:

Common (may occur in fewer than 1 in 10 people):

• Fatigue. In the treatment of hypertension or angina pectoris, this adverse effect occurs uncommonly.
• Dizziness, tiredness, and headache (especially at the beginning of treatment in patients with hypertension and angina pectoris; these symptoms are usually mild and often resolve within 1 to 2 weeks)
• Sensation of coldness or numbness in the extremities (fingers of hands or feet, ears and nose); increased occurrence of cramping leg pain during walking
• Very low blood pressure (hypotension), especially in patients with heart failure
• Nausea, vomiting
• Diarrhea
• Constipation

Uncommon (may occur in fewer than 1 in 100 people):

• Fatigue. In the treatment of heart failure, this effect occurs commonly.
• Drop in blood pressure upon standing, which may cause dizziness, lightheadedness, or fainting
• Sleep disturbances
• Depression
• Irregular heartbeat
• Breathing difficulties in patients with bronchial asthma or a history of respiratory disorders
• Muscle weakness and muscle cramps

Rare (may occur in fewer than 1 in 1,000 people):

• Nightmares
• Hallucinations
• Fainting
• Hearing impairment
• Nasal mucosal inflammation causing watery nasal discharge with irritation
• Skin allergic reactions (such as itching, sudden skin redness, rash)
• Dry eyes due to reduced tear secretion (which may be particularly bothersome in patients using contact lenses)
• Hepatitis, causing abdominal pain, loss of appetite, and sometimes jaundice with yellowing of the eyes and skin, as well as darkening of the urine
• Decreased sexual function (impotence)
• Increased blood lipid levels (triglycerides) and increased liver enzyme activity

Very rare (may occur in fewer than 1 in 10,000 people):

• Worsening of psoriasis symptoms or appearance of similar dry, scaly rash, and hair loss
• Itching or redness of the eyes (conjunctivitis)

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to gather more information on the safety of the medicine.

5. How to store Bibloc

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
No special storage conditions required.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung – batch number/expiry date: see imprint.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Bibloc contains
The active substance is bisoprolol fumarate. Each coated tablet contains 5 mg of bisoprolol fumarate.
The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, pregelatinized corn starch, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, lactose monohydrate, hypromellose, titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172).

What Bibloc looks like and contents of the pack
Yellow, round, film-coated tablets with a score line, marked "BIS 5" on one side. The tablets can be divided into four equal doses.
Film-coated tablets are packed in OPA/Al/PVC/Al blisters in a cardboard box.
Blisters contain 25, 30, 50, 60, 90 or 100 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Germany, the country of export:
Hexal AG
Industriestraße 25
83607 Holzkirchen
Germany

Manufacturer:
Lek S.A.
ul. Podlipie 16
95-010 Stryków
Poland
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing authorisation number in Germany, the country of export: 37243.00.00
Parallel import authorisation number: 35/24